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Management of Headache Disorders: A Clinical Trial Screening for Prognostic Patient Characteristics

A Prospective Randomised Clinical Trial to Investigate the Management of Headache Disorders. Study to Identify Prognostic Patient Characteristics and to Investigate the Additional Value of Physio-/Manual Therapy

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00298142
Enrollment
120
Registered
2006-03-01
Start date
2006-02-28
Completion date
2007-06-30
Last updated
2009-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Headache

Keywords

Cervicogenic Headache, Migraine, Tension Type Headache

Brief summary

The management of headache disorders is too often based upon trial and error or on personal beliefs and opinions. Seldom it is based on scientific arguments. Therefore the identification of prognostic patient characteristics is mandatory as this will lead to a more precise referral of headache patients.A prospective cohortstudy is designed to identify these prognostic patient characteristics. After testing, 186 headache patients (migraine, tension type headache and cervicogenic headache) will be randomly allocated to one of two treatment groups. Testing includes the fulfillment of questionnaires (Headache Diagnosis Questionnaire, Headache Inventory Questionnaire and the Headache Impact Test) and physical tests (Thermal Stimuli, Cervical Spine examination and Pressure Algometry). Treatment groups are a usual care group (administered by a medical doctor) and a usual care plus physio-/ manual therapy treatment. After six weeks of treatment subjects will complete the headache inventory list and the Headache Impact Test a second time. The perceived effect will be registered allowing the distinction between responders (positive effect) and non-responders (no effect or worse). Logistic regression-analysis will be used to identify the specific patient characteristics of the responders and the non-responders. Secondly the additional value of the physio-/ manual therapy intervention will be examined. Follow-up measurements up to 52 weeks are provided.

Interventions

PROCEDUREUsual Care provided by a medical doctor (GP or Neurologist)
PROCEDUREUsual care plus Physio-/ Manual Therapy

Sponsors

Hogeschool Antwerpen
CollaboratorUNKNOWN
Vrije Universiteit Brussel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Dutch speaking * Willing to participate * At least 18 years old * Combination of headache and neck pain * Headache since at least two months and at least twice a month * A combination of migraine, tension type headache and cervicogenic headache

Exclusion criteria

* Clusterheadache * Trigeminusneuralgia * Peripheral neuropathy * A history with neck surgery * Comorbidity with chronic muskuloskeletal pain like fibromyalgia * Radicular pain in the upper extremity * Osteoarthritis * Down Syndroom * Physio/ manual therapy treatment in the last 12 months for this headache complaint. * The use of prescribed medication (like NSAIDs and triptans) for this headache complaint during the last two months * Pregnancy * Red flags as described in the Dutch General Practitioners Headache Guideline

Design outcomes

Primary

MeasureTime frame
HIT-6
Manual Examination of the Cervical Spine
Pressure algometry
Thermal stimulation
Perceived effect

Secondary

MeasureTime frame
Frequency of headache
Intensity of headache
Medication Intake
Additional Profession help
Absenteism

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026